Reversal of sedation

Active Ingredient: Flumazenil

Indication for Flumazenil

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

For the reversal of conscious sedation induced with benzodiazepines in children above 1 year of age.

For this indication, competent medicine agencies globally authorize below treatments:

10-50 ug/kg in 1-5 divided doses

Route of admnistration

Intravenous

Defined daily dose

10 - 50 ug per kg of body weight

Dosage regimen

From 2 To 10 ug per kg of body weight 5 time(s) per day every day

Detailed description

For the reversal of conscious sedation induced with benzodiazepines in children above 1 year of age, the recommended initial dose is 10 micrograms/kg (up to 200 micrograms) administered intravenously over 15 seconds. If the desired level of consciousness is not obtained after waiting an additional 45 seconds, further injection of 10 micrograms/kg may be administered (up to 200 micrograms) and repeated at 60 second intervals where necessary (a maximum of 4 times) to a maximum total dose of 50 micrograms/kg or 1000 micrograms, whichever is lower. The dose should be individualised based on the patient’s response. No data are available on the safety and efficacy of repeated administration of flumazenil to children for re-sedation.

Active ingredient

Flumazenil

Flumazenil, an imidazobenzodiazepine, is a benzodiazepine antagonist which, by competitive interaction, blocks the effects of substances acting via the benzodiazepine-receptor. Neutralisation of paradoxal reactions of benzodiazepines has been reported.

Read more about Flumazenil

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